BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM REG IMPLANT

    MDR report key: 7206717 · Received January 19, 2018

    Report

    Report Number
    8020776-2018-00098
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    November 27, 2017
    Report Date
    January 19, 2018
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000055
    PMA / PMN Number
    K101913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUAL SCREWING OF THE HEALING SCREW WAS ON THAT CASE PROBABLY TO HIGH ( >10 N.CM).THE PRACTITIONER HAS NEITHER RESPECTED THE MANUAL TIGHTENING PROTOCOL (< 10 N.CM) OF THE HEALING SCREW NOR THE SINGLE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE PRACTITIONER HAS PLACED THE IMPLANT AT A TORQUE OF 50 N.CM AND HAS SCREWED ONE HEALING SCREW ON THE IMPLANT ON (B)(6) 2017. TWO MONTHS LATER, IN ORDER TO PLACE THE PROSTHETIC PART, HE TRIED TO UNSCREW THE HEALING SCREW WITHOUT SUCCESS. TRYING TO UNSCREW THE HEALING SCREW, HE FINALLY BROKE HIS SCREWDRIVER. IN THESE CIRCUMSTANCES, IT WAS IMPOSSIBLE TO UNSCREW AND REMOVE THE HEALING SCREW WITHOUT REMOVING THE IMPLANT. THE IMPLANT HAS BEEN RETURNED WITH AN HEALING SCREW REF. (B)(4) (Ø6.0 H2.0). THE LOT NUMBER OF THE HEALING SCREW IS UNKNOWN (NOT COMMUNICATED BY THE PRACTITIONER). THE IMPLANT HAS BEEN PLACED IN 36 POSITION ON (B)(6) 2017 AND HAS BEEN EXPLANTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48918 AXIOM REG IMPLANT IMPLANT AXIOM D.3.4 X 8.0 DZE ANTHOGYR OP34080 17-185313 03663394000055

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR